Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section

Comparisons of the Blood Pressure Control Ability Between Hypotension Prediction Index With Non-invasive Continuous Arterial Pressure Waveforms, Continuous Blood Pressure Monitoring With Non-invasive Continuous Arterial Pressure Waveforms, and Intermittent Blood Pressure Monitoring With Conventional Non-invasive Blood Pressureduring Neuraxial Anesthesia in Cesarean Section: a Randomized Controlled Trial

The goal of this study is to compare the blood pressure control ability with HPI, ClearSight, and conventional NIBP during neuraxial anesthesia in cesarean section. The main question it aims to answer is:

Anesthesiologists can have a better control of blood pressure during cesarean section with HPI than with conventional NIBP.

During the surgery, the participants will be monitored with standard monitor and HPI with ClearSight and will be randomly assigned to three groups, including HPI group, ClearSight group, and NIBP group. Anesthesiologists will treat intraoperative hypotension with different protocols according to the participants' allocation. Investigators will compare the time-weighted average mean arterial pressure < 65mmHg with in three groups. Secondary outcomes includes the intraoperative hypotension rate, total duration of hypotension, the hypotension symptoms and signs of parturients.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section; Intraoperative Hypotension
• Intervention / Treatment: Device: hypotension prediction index derived from non-invasive arterial pressure waveforms; Device: non-invasive arterial pressure waveforms

• Study Type: Interventional
• Enrollment (Estimated): 255
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Po-Yuan Shih, MD; Phone Number: 262158 886-2-23123456; Email: shih.poyuan@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Po-Yuan Shih

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 20 - 50 year-old parturients
• scheduled cesarean delivery
• neuraxial anesthesia

Exclusion Criteria:

• parturients with preeclampsia
• parturients with cardiovascular disease above NYHA functional class 2
• parturients with arrhythmias, preoperative severe hypertension, or other severe cardiopulmonary diseases.
• severe perioperative arrhythmias with or without hemodynamic instability
• failed neuraxial anesthesia or regional blockade level below T6

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPI; Standard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and hypotension prediction index (HPI) derived from ClearSight are used for recording and monitoring. Blood pressure is monitored with ClearSight and HPI. Attending anesthesiologists controlled the blood pressure according to HPI values.; Maintain HPI below 85; HPI > 85 and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg; HPI > 85 and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg	Device: hypotension prediction index derived from non-invasive arterial pressure waveforms; The Hypotension Prediction Index (HPI) is an algorithm based on the complex analysis of features in high-fidelity arterial pressure waveform recordings developed to observe subtle signs that could predict the onset of hypotension in surgical and intensive care unit patients. HPI is a unitless number that ranges from 1 to 100, and as the number increases, the likelihood of a hypotensive event (MAP <65 mm Hg for more than 1 minute) occurring in the near future increases. In a validation study on HPI conducted in patients under general anesthesia, the algorithm, at its optimal value, predicted hypotension with both sensitivity and specificity of 86% 5 minutes before the event. Measurement of the arterial pressure waveforms using a finger cuff (ClearSight) is well established.
Active Comparator: ClearSight; Standard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and HPI derived from ClearSight are used for recording, and HPI are masked for attending anesthesiologists. Blood pressure is monitored with ClearSight. Attending anesthesiologists controlled the blood pressure according to continuous arterial pressure values.; Maintain mean arterial pressure (MAP) above 65 mmHg; MAP < 65mmHg and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg; MAP < 65mmHg and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg	Device: non-invasive arterial pressure waveforms; ClearSight is a non-invasive hemodynamic monitoring device using digital-cuff and volume-clamp technology to obtain a continuous arterial blood pressure waveform. Continuous finger blood pressure measurement is established by wrapping the cuff around the middle phalanx of a finger. The area under the waveform curve is analyzed using a unique algorithm that serves to calculate the arterial blood pressure, stroke volume (SV) and CO.
No Intervention: NIBP; Standard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and HPI derived from ClearSight are used for recording, and are masked for attending anesthesiologists. Blood pressure is monitored with conventional non-invasive blood pressure (NIBP). Attending anesthesiologists controlled the blood pressure according to continuous arterial pressure values.; Maintain mean arterial pressure (MAP) above 65 mmHg; MAP < 65mmHg and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg; MAP < 65mmHg and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time-weighted MAP below 65 mmHg	through the surgery completion, an average of 1.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rates of parturients with intraoperative hypotension	hypotension is defined as MAP below 65 mmHg for more than 1 minute	through the surgery completion, an average of 1.5 hours
total hypotension duration	hypotension is defined as MAP below 65 mmHg for more than 1 minute	through the surgery completion, an average of 1.5 hours
area under curve of hypotension	hypotension is defined as MAP below 65 mmHg for more than 1 minute	through the surgery completion, an average of 1.5 hours
total vasopressor dosage	average norepinephrine dosage used during the surgery	through the surgery completion, an average of 1.5 hours
rate of hypotension related symptoms and sign of the parturients	symptoms and signs include nausea, vomiting, bradycardia, dizziness, and shivering	through the surgery completion, an average of 1.5 hours
average regional cerebral oxygen saturation		through the surgery completion, an average of 1.5 hours

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• Frassanito L, Sonnino C, Piersanti A, Zanfini BA, Catarci S, Giuri PP, Scorzoni M, Gonnella GL, Antonelli M, Draisci G. Performance of the Hypotension Prediction Index With Noninvasive Arterial Pressure Waveforms in Awake Cesarean Delivery Patients Under Spinal Anesthesia. Anesth Analg. 2022 Mar 1;134(3):633-643. doi: 10.1213/ANE.0000000000005754.
• Misugi T, Juri T, Suehiro K, Kitada K, Kurihara Y, Tahara M, Hamuro A, Nakano A, Koyama M, Mori T, Tachibana D. Non-invasive continuous blood pressure monitoring using the ClearSight system for pregnant women at high risks of post-partum hemorrhage: comparison with invasive blood pressure monitoring during cesarean section. Obstet Gynecol Sci. 2022 Jul;65(4):325-334. doi: 10.5468/ogs.22063. Epub 2022 Jun 27.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 11, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 202210114RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No